Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 56007 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Center for Food Safety and Applied 

Nutrition at 1–888–SAFEFOOD, Fax: 1–

877–366–3322, or by e-mail: 

industry@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 9, 

2004 (69 FR 71562), FDA issued a final 

rule to implement section 306 of the 

Bioterrorism Act. The regulation 

requires the establishment and 

maintenance of records by persons who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

in the United States. Such records are to 

allow for the identification of the 

immediate previous sources and the 

immediate subsequent recipients of 

food. Persons subject to the regulation 

who employ 500 or more FTEs had to 

be in compliance by December 9, 2005, 

and those who employ 11–499 FTEs had 

to be in compliance by June 9, 2006. 

Persons who employ 10 or fewer FTEs 

have until December 11, 2006 to be in 

compliance. ‘‘Person’’ includes an 

individual, partnership, corporation, 

and association. 

On September 12, 2005, FDA issued 

the first edition of a guidance entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records.’’ On November 22, 2005, FDA 

issued a second edition of that guidance 

and on June 6, 2006, FDA issued a third 

edition of that guidance. This document 

is the fourth edition of that guidance 

entitled ‘‘Questions and Answers 

Regarding Establishment and 

Maintenance of Records (Edition 4)’’

and responds to questions regarding 

persons covered by the regulation, and 

persons excluded by the regulation, 

including additional guidance on the 

farm exclusion. In addition, we are 

amending the response to question 4.2 

to clarify that while post-harvesting 

activities related to hay are subject to 

the rule, certain activities that are part 

of harvesting remain within the farm 

exemption. This guidance is intended to 

help the industry better understand and 

comply with the regulation in 21 CFR 

part 1, subpart J. FDA is issuing this 

guidance as a Level 1 guidance. The 

guidance represents the agency’s current 

thinking on the topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. 

Consistent with FDA’s good guidance 

practices regulation § 10.115(g)(2) (21 

CFR 10.115), the agency will accept 

comments, but it is implementing the 

guidance document immediately, in 

accordance with § 10.115(g)(2), because 

the agency has determined that prior 

public participation is not feasible or 

appropriate. As noted, persons who 

employ 500 or more FTEs had to begin 

to establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food by December 9, 2005, 

and those who employ 11–499 FTEs had 

to be in compliance by June 9, 2006. 

Persons who employ 10 or fewer FTEs 

have until December 11, 2006, to be in 

compliance. Clarifying the provisions of 

the final rule will facilitate prompt 

compliance with these requirements 

and complete the rule’s implementation. 

FDA continues to receive large 

numbers of questions regarding the 

records final rule, and is responding to 

these questions under § 10.115 as 

promptly as possible, using a questionand-answer format. The agency believes 

that it is reasonable to maintain all 

responses to questions concerning 

establishment and maintenance of 

records in a single document that is 

periodically updated as the agency 

receives and responds to additional 

questions. The following four indicators 

will be employed to help users of this 

guidance identify revisions: (1) The 

guidance will be identified as a revision 

of a previously issued document, (2) the 

revision date of the guidance will 

appear on its cover, (3) the edition 

number of the guidance will be 

included in its title, and (4) questions 

and answers that have been added to the 

original guidance will be identified as 

such in the body of the guidance. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance at any 

time. Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments and the guidance may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.cfsan.fda.gov/~dms/ 

recguid3.html. 

Dated: September 20, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8241 Filed 9–21–06; 1:22 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs for Use in Animal 

Feeds; Lasalocid 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by 

Purina Mills, Inc. The supplemental 

NADA provides for the use of a 

lasalocid Type A medicated article 

containing 20 percent lasalocid activity 

per pound to make free-choice Type C 

medicated feed mineral blocks used for 

increased rate of weight gain in pasture 

cattle (slaughter, stocker, feeder cattle, 

and dairy and beef replacement heifers). 

DATES: This rule is effective September 

26, 2006. 

FOR FURTHER INFORMATION CONTACT: Eric 

S. Dubbin, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0232, email: eric.dubbin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Purina 

Mills, Inc., P.O. Box 66812, St. Louis, 

MO 63166–6812, filed a supplement to 

NADA 141–171 for use of BOVATEC 91 

(lasalocid) Type A medicated article to 

make Purina Sugar Mag Block 1440 BVT 

Medicated Mineral Block, a free-choice 

Type C medicated feed used for 

increased rate of weight gain in pasture 

cattle (slaughter, stocker, feeder cattle, 

and dairy and beef replacement heifers). 

The supplement provides for the use of 

a lasalocid Type A medicated article 

containing 20 percent lasalocid activity 

per pound. The supplemental NADA is 

approved as of August 18, 2006, and the 

regulations are amended in § 558.311 

(21 CFR 558.311) to reflect the approval. 


rmajette on PROD1PC67 with RULES1
56008 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 

The basis of approval is discussed in the 

freedom of information summary. 

In addition, FDA is amending 

§ 558.311 to remove redundant text in 

an entry for combination use of singleingredient lasalocid and 

chlortetracycline in cattle feed which 

was published in error in the Federal 

Register of April 27, 2006 (71 FR 

24816). This correction is being made to 

improve the accuracy of the regulations. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33(a)(6) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 558 

Animal drugs, Animal feeds. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.311 [Amended] 

■ 2. In § 558.311, in paragraph (b)(8), 

after the number ‘‘15’’ add the words 

‘‘and 20’’; and in paragraph (e)(1)(xxvii) 

in the ‘‘Indications for use’’ column, 

remove ‘‘control of control of’’ and in its 

place add ‘‘control of’’. 

Dated: September 15, 2006. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 06–8261 Filed 9–25–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1309, 1310, 1314 

[Docket No. DEA–291I] 

RIN 1117–AB05 

Retail Sales of Scheduled Listed 

Chemical Products; Self-Certification 

of Regulated Sellers of Scheduled 

Listed Chemical Products 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Interim final rule with request 

for comment. 

SUMMARY: In March 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005, which establishes 

new requirements for retail sales of 

over-the-counter (nonprescription) 

products containing the List I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. The three 

chemicals can be used to manufacture 

methamphetamine illegally. DEA is 

promulgating this rule to incorporate 

the statutory provisions and make its 

regulations consistent with the new 

requirements. This action establishes 

daily and 30-day limits on the sales of 

scheduled listed chemical products to 

individuals and requires recordkeeping 

on most sales. 

DATES: Effective Dates: September 21, 

2006, except that §§ 1314.20, 1314.25, 

and 1314.30 (with the exception of 

§ 1314.30(a)(2)) are effective September 

30, 2006. Section 1314.30(a)(2) is 

effective November 27, 2006. 

Comment Date: Written comments 

must be postmarked on or before 

November 27, 2006. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–291I’’ on all written and 

electronic correspondence. Written 

comments being sent via regular mail 

should be sent to the Deputy 

Administrator, Drug Enforcement 

Administration, Washington, DC 20537, 

Attention: DEA Federal Register 

Representative/ODL. Written comments 

sent via express mail should be sent to 

DEA Headquarters, Attention: DEA 

Federal Register Representative/ODL, 

2401 Jefferson-Davis Highway, 

Alexandria, VA 22301. Comments may 

be directly sent to DEA electronically by 

sending an electronic message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the http:// 

www.regulations.gov Web site. DEA will 

accept attachments to electronic 

comments in Microsoft word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file format other than those specifically 

listed here. 

FOR FURTHER INFORMATION CONTACT: 

Mark W. Caverly, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537; 

telephone: (202) 307–7297. 

SUPPLEMENTARY INFORMATION: 

DEA’s Legal Authority 

DEA implements the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, often referred to as the 

Controlled Substances Act (CSA) and 

the Controlled Substances Import and 

Export Act (21 U.S.C. 801–971), as 

amended. DEA publishes the 

implementing regulations for these 

statutes in Title 21 of the Code of 

Federal Regulations (CFR), Parts 1300 to 

1399. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and to deter the 

diversion of controlled substances to 

illegal purposes. The CSA mandates that 

DEA establish a closed system of control 

for manufacturing, distributing, and 

dispensing controlled substances. Any 

person who manufactures, distributes, 

dispenses, imports, exports, or conducts 

research or chemical analysis with 

controlled substances must register with 

DEA (unless exempt) and comply with 

the applicable requirements for the 

activity. The CSA as amended also 

requires DEA to regulate the 

manufacture and distribution of 

chemicals that may be used to 

manufacture controlled substances 

illegally. Listed chemicals that are 

classified as List I chemicals are 

important to the manufacture of 

controlled substances. Those classified 

as List II chemicals may be used to 

manufacture controlled substances. 

On March 9, 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005 (CMEA), which is 

Title VII of the USA PATRIOT 

Improvement and Reauthorization Act 

of 2005 (Pub. L. 109–177). DEA is 

promulgating this rule as an interim 

final rule rather than a proposed rule 

because the changes being made codify 

statutory provisions, some of which are 

already in effect. Parts of the statute are 

self-implementing; certain changes 

related to retail sales became effective 

upon signature (March 9, 2006), others 


rmajette on PROD1PC67 with RULES1